BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIMBERLY CLARK PERCUTANEOUS GJ TUBE KIT, W/ ANCHORS

    MDR report key: 1628686 · Received March 5, 2010

    Report

    Report Number
    MW5015047
    Event Type
    Injury
    Date Received
    March 5, 2010
    Report Date
    March 5, 2010
    Manufacturer
    KIMBERLY CLARK
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COMPLICATIONS RELATED TO KIMBERLY CLARK PERCUTANEOUS G/GJ TUBE ANCHORS. OF THE 5 MOST RECENTLY PLACED PERCUTANEOUS GJ TUBES, WE HAVE HAD 4 ANCHOR RELATED COMPLICATIONS. THE INITIAL PTS HAD ANCHORS WHICH WENT THROUGH BOTH THE ANTERIOR AND POSTERIOR STOMACH WALL DURING INSERTION. THIS COMPLICATION WAS ADDRESSED BY PERFORMING ALL THE PROCEDURE WITH ENDOSCOPY TO CONFIRM THAT THE ANCHORS WERE INTRALUMINAL. DATES OF USE: 1 YEAR, (B) (6) 2008 - (B) (6) 2009. DIAGNOSIS OR REASON FOR USE: MEDICALLY COMPLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY CLARK PERCUTANEOUS GJ TUBE KIT, W/ ANCHORS NONE KNT KIMBERLY CLARK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization